Quality of Recovery After Reversal With Neostigmine or Sugammadex.

Phase 4

Completed

Conditions: Incomplete Reversal of Neuromuscular Block

Interventions: Drug: Neostigmine
Drug: Sugammadex

Registration Number: NCT02909439

Lead Sponsor: Stony Brook University

Brief Summary: This study will compare patient recovery measures after reversal of neuromuscular blockade with neostigmine or sugammadex after surgery. Measures include pulmonary function, muscle strength, time to extubation and quality of recovery in the post anesthesia care unit.

Detailed Description: Sugammadex has been shown to have a faster onset and more reliable reversal of neuromuscular blockade when compared to neostigmine as measured by return of Train-of-four (TOF) ratio to \>0.9. (Breuckmann, 2015) The investigator's hypothesis is that sugammadex will be associated with improved deep breathing as measured by incentive spirometry in the PACU. The investigators also hypothesize that patients reversed with sugammadex will have shorter times to extubation and better recovery profiles in the PACU as measured by strength, PACU discharge readiness and quality of recovery scores.

Residual neuromuscular blockade after surgery can result in airway compromise, pulmonary complications, and possible need for reintubation and can be a negative experience for patients. Reintubation after surgery is currently a quality measure in NSQIP (National Surgery Quality Improvement Program) A TOF ratio of \<0.9 has been identified as a marker of residual neuromuscular blockade in the PACU. (Farhan 2013) Several clinical trials have shown that reversal of neuromuscular blockade with sugammadex results in a faster and more reliable return to TOF ratio of \>0.9 when compared to neostigmine. However most of these studies primarily report on TOF ratios. There are scant data on clinical outcomes after reversal with neostigmine versus sugammadex. Incentive spirometry is a clinically meaningful measurement of postoperative pulmonary function, i.e the ability to breath deeply, which minimizes atelectasis and risk of postoperative pneumonia.

The investigators will compare recovery profiles of patients who have received sugammadex or neostigmine for reversal of neuromuscular blockade after surgery. The primary outcome will be incentive spirometry volumes after surgery as a measure of pulmonary function. The secondary measures include hand grip measured using a dynamometer, time to extubation, time to PACU discharge, time to sit independently, and quality of recovery 15 survey scores.

This will be a single-center, prospective, randomized, assessor blinded, controlled trial. Patients will be randomized to either receive sugammadex or neostigmine for the reversal of neuromuscular blockade. The anesthesiologist will be unblinded to the study drug however the assessor in the PACU will be blinded.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Participant must be willing and able to provide written informed consent for the study
Participant must be greater than or equal to 18 years of age
Participant must be ASA (American Society of Anesthesiologists) class I, II or III
Planned use of neuromuscular blocking drugs
Planned use of endotracheal intubation
Planned for extubation to occur in the OR

Exclusion Criteria

ASA (American Society of Anesthesiologists) Class IV
Age < 18 years old
Inability to give oral or written consent
Known or suspected neuromuscular disorder impairing neuromuscular function
True allergy to muscle relaxants
A (family) history of malignant hyperthermia
A contraindication for neostigmine or sugammadex administration
Serum creatinine level of greater than 2.0 mg/dL
Surgery where the patient's arm is not available for neuromuscular monitoring
A plan to extubate under deep anesthesia
Pregnant

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine	Neostigmine	Patients in this arm will receive neostigmine for reversal of neuromuscular blockade. Neostigmine is historically the medication that has been used for this purpose.
Sugammadex	Sugammadex	Patients in this arm will receive sugammadex for reversal of neuromuscular blockade. Sugammadex is a newer, FDA approved, medication for this purpose.

Primary Outcome Measures

Name	Time	Method
Incentive Spirometry, Change From Baseline and Recovery Profile - 30 Minutes	30 Minutes	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Incentive Spirometry, Change From Baseline and Recovery Profile - 60 Minutes	60 Minutes after reversal	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.
Incentive Spirometry, Change From Baseline and Recovery Profile - 120 Minutes	120 minutes after reversal	Incentive spirometry measurements will be done at 30, 60 and 120 minutes after surgery. The change from baseline and recovery profile will be measured.

Secondary Outcome Measures

Name	Time	Method
Time to Extubation	Immediately after surgery, up to 30 minutes	Measured time between surgery end and time of extubation (removal of breathing tube)
Grip Strength, Change From Baseline and Recovery Profile 30 Min	30 minutes	Grip strength will be measured with a hand dynamometer
Grip Strength, Change From Baseline and Recovery Profile 60 Min	60 minutes after reversal	Grip strength will be measured with a hand dynamometer
Grip Strength, Change From Baseline and Recovery Profile 120 Min	120 minutes after surgery	Grip strength will be measured with a hand dynamometer
Time to Readiness for Post Anesthesia Care Unit (PACU) Discharge (Aldrete Score >9)	Within 4 hours from the end of surgery	Measured time between PACU admission and meeting PACU discharge readiness. PACU discharge was defined as when the patient had an Aldrete score of 9 or higher as determined by the PACU nurse. The Aldrete score is a measure of post anesthesia recovery. 0 is poor condition and 10 is excellent condition. There are 5 assessment items (able to move voluntary, breathing, consciousness, circulation (BP) and spO2) which are graded on a 0-2 point scale with 0 being poor and 2 being excellent.
Train of Four Ratio > 90% During PACU Admission	At PACU admission, approximately within one hour of reversal of neuromuscular blockade reversal.	Train of four ratio (TOFR) is the ration of the twitch height of the 4th twitch compared to the 1st twitch during train of four neuromuscular stimulation. This measurement was performed using a TOF Watch, which in an accelemyographer. Electric current is applied to the ulnar nevre and the twitches are measured in the thumb. Adequate reversal of neuromuscular blockade is defined as a TOFR \>90%.
Quality of Recovery 15 Survey	Postoperative day number one	15 question survey to assess patient's overall quality of recovery after anesthesia/surgery. Quality of Recovery 15 Survey. Minimum: 0 Maximum: 150 Higher Scores mean a better outcome and better quality of recovery. Part A: How have you been feeling in the last 24 hours? 0 = none of the time (poor), 10 = all of the time (excellent). Examples: able to breath easily, able to enjoy food, feeling rested. etc. Part B: Have you had any of the following in the last 24 hours? 10 to 0, where 10 = none of the time (Excellent) and 0 = all of the time (poor). Examples: moderate pain, nausea or vomiting, feeling worried or anxious, etc.